OVENT
K-Number: K160234 · 2016-03-17
ApplicantOventus Manufacturing Pty, Ltd.
Decision Date2016-03-17
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
OVENT is a medical device manufactured by Oventus Manufacturing Pty, Ltd.. It received FDA 510(k) clearance on 2016-03-17 under approval number K160234. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OVENT?
OVENT is a medical device that received FDA 510(k) clearance on 2016-03-17. It is manufactured by Oventus Manufacturing Pty, Ltd.. The 510(k) number is K160234.
When was OVENT approved by the FDA?
OVENT received FDA 510(k) clearance on 2016-03-17, under approval number K160234.
What company makes OVENT?
OVENT is manufactured by Oventus Manufacturing Pty, Ltd..
What is the FDA product code for OVENT?
The FDA product code for OVENT is LRK.
Other Devices by Oventus Manufacturing Pty, Ltd.
Related Devices (Code: LRK)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.